Clementia Pharmaceutical Inc., of Montreal, filed its F-1 with the SEC to raise up to $115 million in an IPO. The company is developing lead compound palovarotene, a retinoic acid receptor gamma agonist, to treat fibrodysplasia ossificans progressiva (FOP) and multiple osteochondroma (MO). Read More
Theratechnologies Inc., of Montreal, said it was notified by partner Taimed Biologics Inc., of Taipei, Taiwan, that the FDA accepted for review the BLA for ibalizumab as a treatment for multidrug-resistant HIV-1. Read More
Boston Biomedical Inc., of Cambridge, Mass., reported data from a phase Ib/II trial testing napabucasin in metastatic colorectal cancer (mCRC) and pancreatic adenocarcinoma (mPDAC) at the European Society of Medical Oncology 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) will start accepting priority review applications, and it has expanded its orphan drug designation criteria, thanks to new legislation passed earlier this month that overhauls the country's drug regulations. Read More
Indi Molecular has an impressive pedigree, having been founded in 2013 by Leroy Hood of the Institute of Systems Biology, James Heath of Caltech and diagnostics entrepreneur Albert Luderer. It's a spinout from parent company Integrated Diagnostics that was first seeded with $1.8 million from Interwest Partners, Asset Management Ventures and angel investors. Read More
Illumina Inc. is set to provide its sequencing cancer companion diagnostic test kit to be used along with Amgen Inc.'s EGFR-targeting drug, Vectibix (panitumumab), which earned a supplemental approval for use as a first-line treatment in wild-type RAS metastatic colorectal cancer patients in combination with FOLFOX and as a monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin and irinotecan-containing chemotherapy. Read More
Efficacy against acute exacerbations of schizophrenia looks strong in top-line phase III data from the four-week Enlighten-1 trial with Alkermes plc's ALKS-3831, but the world won't know until next year about the weight gain and metabolic aspects investigated by a six-month experiment called Enlighten-2. Read More
"This is why you do a phase II," H.C. Wainwright & Co. analyst Corey Davis headlined his note assessing top-line data posted by Cara Therapeutics Inc. on its phase IIb trial of the oral formulation of its peripherally selective kappa opioid agonist, CR-845, in patients with osteoarthritis (OA) of the knee or hip. Read More
Clogged cartridge filters and the trial failure they likely caused battered shares of Windtree Therapeutics Inc. (OTCQB:WINT), sending the stock falling 61.8 percent Friday, or 53 cents, to close at 33 cents on news that its aerosolized medicine for preemies with respiratory distress syndrome, Aerosurf, failed to diminish the need for intubation, missing the trial's primary endpoint. Read More
Researchers from the International Mouse Phenotypic Consortium have published the comprehensive phenotypes of more than 3,300 knockout mice, describing mouse models for 360 diseases. Read More
